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Anesthesia Device Recall; Patient Data Does Not Match


McKesson Anesthesia Care was recalled because there was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death.

 

McKesson Anesthesia Care is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

See also Medical Law Perspectives, November 2012 Report: Liability for Electronic and Other Medical Record Information Disclosure

 

 

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